[ad_1]
This Quarterly Report on Form 10-Q contains predictions, estimates and other
forward-looking statements relating to future events or our future financial
performance. In some cases, you can identify forward-looking statements by
terminology such as “may,” “should,” “intends,” “expects,” “plans,”
“anticipates,” “believes,” “estimates,” “predicts,” “potential,” or “continue”
or the negative of these terms or other comparable terminology. Forward-looking
statements involve known and unknown risks, uncertainties and other factors
including the risks set forth in the section entitled “Risk Factors” in our
prospectus, as filed with the
to be materially different from any future results, performances or achievements
expressed or implied by the forward-looking statements.
Forward-looking statements represent our management’s beliefs and assumptions
only as of the date of this Report. You should read this Report with the
understanding that our actual future results may be materially different from
what we expect.
All forward-looking statements speak only as of the date on which they are made.
We undertake no obligation to update such statements to reflect events that
occur or circumstances that exist after the date on which they are made, except
as required by federal securities and any other applicable law.
The management’s discussion and analysis of our financial condition and results
of operations are based upon our condensed unaudited financial statements, which
have been prepared in accordance with accounting principles generally accepted
in
The following discussion of our financial condition and results of operations
should be read in conjunction with the notes to the unaudited financial
statements appearing elsewhere in this Report and the Company’s audited
financial statements for the fiscal year ended
the
accompanying notes. As used in this Quarterly Report, the terms “we,” “us,”
“our” and the “Company” means
The Company has relied primarily on its two co-founders,
Executive Officer, and
manage its day-to-day business and has outsourced professional services to third
parties in an effort to maintain lower operational costs.
Messrs. Meer and Merfeld, as the holders of the Company’s issued and outstanding
shares of the Company’s Class A Preferred Stock, collectively have 66 2/3% of
the voting rights of the Company. Acting together, they will be able to
influence the outcome of all corporate actions requiring approval of our
stockholders.
Plan of Operations
We are an innovative biotechnology company dedicated to developing biotech
products, treatments and technologies that create a platform to combat neuronal
diseases. We seek to engage in strategic arrangements with companies and
institutions that are developing breakthrough technologies in the fields of
artificial intelligence and machine learning, molecular biology, stem cells and
tissue engineering, for deployment in the fight against neuronal diseases. Our
search is focused on researchers based in
world-renowned for biotech innovations and where its President is located and
where its research to date has been conducted.
To date, the Company has collaborated with universities and scientists in the
fields of regenerative medicine, tissue engineering and 3D printable hydrogels
to develop a treatment that integrates proprietary, engineer mesenchymal stem
cells (“MSCs”), 3D printable implant, smart materials and a novel delivery
system and has two product candidates for treating penetrating and
non-penetrating (concussion-like) traumatic brain injuries, both integrating
proprietary, anti-brain inflammation synthetic hydrogel and modified MSCs.
As a result of the Company’s multidiscipline research effort in the field of
supramolecular and polymeric materials chemistry and neuronal tissue
engineering, on
application for inventions of therapeutic polypseudorotaxane hydrogels, thereby
providing the Company with the option to, in the future, seek protection for
these inventions globally. The patent application relates generally to the
treatment of pathological central nervous system conditions such as traumatic
injury or neurodegenerative disease and the applications of uses of hydrogels in
the treatment of such conditions.
On
PhD in Molecular Biology and Neuroscience based on his submission of his paper
entitled Mesenchymal Stem Cells integrated into Pseudopolyrotaxane hydrogels
promote neuronal stem cells maturation and inhibits reactive Astrocytes and
Activated Microglia after penetrating traumatic brain injury, based on the
research done at
We have not generated any revenue from the sale of products.
21
Table of Contents
Results of Operations
Three Months Ended
Revenue
We have not generated any revenue since our inception and do not expect to
generate any revenue from the sale of products in the near future.
Net Loss We had net income of$75,764 in the three months endedSeptember 30, 2022 compared to net loss of$79,880 in the three months endedSeptember 30, 2021 , as follows: Three Months ended September 30, 2022 2021 Net sales $ - $ - Operating expenses: Research and development expenses 6,250 9,076 Professional fees 8,999 11,868 General and administrative expenses 7,202 9,363 Total operating expenses 22,451 30,307 Loss from operations (22,451 ) (30,307 ) Other income (expense) Interest expense (6,875 ) (43,526 )
Change in fair market value of derivative liabilities 105,090 (6,047 )
Total other income (expense)
98,215 (49,573 ) Net income (loss)$ 75,764 $ (79,880 ) Operating Expenses
Total operating expenses for the three months ended
ended
months ended
administrative fees from
research and development expenses from
a decreases in professional fees from
During the three months ended
of research and development expenses which included licensing fees of
software license and equipment costs of
and development fees for the three months ended
comprised solely of licensing fees of
administrative fees for the three months ended
to a decrease in branding and marketing expenses in the three-month period ended
22
Table of Contents
Other Income (Expense)
Other income in the three months ended
included a gain of
certain derivative liabilities, offset by interest expense of
expense in the three months ended
included a loss of
liabilities, and interest expense of
of convertible notes of
payable of
Nine Months Ended
Revenue
We have not generated any revenue since our inception and do not expect to
generate any revenue from the sale of products in the near future.
Net Loss
We had a net loss of
compared to
For the Nine Months Ended
September 30,
2022 2021
Net sales $ - $ -
Operating expenses:
Research and development expenses 23,596 32,262
Professional fees 62,904 35,808
General and administrative expenses 30,571 43,398
Total operating expenses 117,071 111,468
Loss from operations (117,071 ) (111,468 )
Other income (expense)
Interest expense (69,406 ) (166,270 )
Change in fair market value of derivative liabilities 69,875 (2,877 )
Total other income (expense) 379 (169,147 )
Net loss $ (116,692 ) $ (280,615 )
23
Table of Contents
Operating Expenses
Total operating expenses for the nine months ended
ended
nine months ended
professional fees from
and accounting fees in connection with the Company’s filing of a registration
statement and prospectus in the nine months ended
a decrease in research and development activities from
months ended
30, 2021
for the nine months ended
ended
Company incurred
service fees related to certain research and development agreements of
technology licensing fees of
of
included service fees related to certain research and development agreements of
and purchases of expendable lab supplies and equipment of
months ended
fees for the nine months ended
months ended
30, 2022
Other Income (Expense)
Other income in the nine months ended
a gain of
and interest expense of
notes of
expense in the nine months ended
included a loss of
liabilities, and interest expense of
of convertible notes of
on convertible notes payable of
Operating Activities
Net cash used in operating activities was
2021
30, 2022
gain on change in fair market value of derivative liabilities of
by non-cash items accretion of debt discount of
assets and liabilities, including an increase to accounts payable of
an increase to accounts payable-related parties of
operating activities for the nine months ended
the result of net loss, offset by non-cash items, including compensation in the
form of stock options for research and development expense of
of debt discount of
liabilities of
operating assets and liabilities, including an increase to prepaid expenses of
payable-related parties of
Investing Activities
There were no investing activities during the nine months ended
2022
Financing Activities
Net cash provided by financing activities was
2022
proceeds of
in the form of unsecured advances.
24
Table of Contents
Liquidity and Capital Resources
As of
development and have experienced net losses to date and have not generated
revenue from operations which raises substantial doubt about our ability to
continue as a going concern. There are a number of conditions that we must
satisfy before we will be able to commercialize potential products and generate
revenue, including successful development of product candidates, which includes
clinical trials, FDA approval, demonstration of effectiveness sufficient to
generate commercial orders by customers, establishing production capabilities as
well as effective marketing and sales capabilities for our product. We do not
currently have sufficient resources to accomplish any of these conditions
necessary for us to generate revenue and expect to incur increasing operating
expenses. We will require substantial additional funds for operations, the
service of debt and to fund our business objectives. There can be no assurance
that financing, whether debt or equity, will be available to us in the amount
required at any particular time or for any particular period or, if available,
that it can be obtained on terms favorable to us. If additional funds are raised
by the issuance of equity securities, such as through the issuance and exercise
of warrants, then existing stockholders will experience dilution of their
ownership interest. If additional funds are raised by the issuance of debt or
other equity instruments, we may be subject to certain limitations in our
operations, and issuance of such securities may have rights senior to those of
the then existing stockholders. We currently have no agreements, arrangements or
understandings with any person or entity to obtain funds through bank loans,
lines of credit or any other sources.
As we continue to monitor the impact of the COVID-19 outbreak, we continue
exploring sources of debt and equity financings as well as available grants. We
are currently exploring and are in discussions for potential strategic
alternatives in the biotechnology field which could advance our MSCs and
neurodegenerative research. There can be no assurance the necessary financing
will be available or that a suitable strategic partner will be identified. In
such event, we may explore relationships with third parties to develop or
commercialize products or technologies that we have not previously sought to
develop or commercialize, decide to exit our existing business, cease operations
altogether or pursue an acquisition of our company. However, without additional
financing, we do not believe our resources will be sufficient to meet our
operating and capital needs beyond the fiscal year ended 2022.
Offering
The Company filed a registration statement on Form S-1 with the
11, 2022
self-underwritten primary offering at a fixed price of
declared effective on
there can be no assurance that the Company will be successful in selling any of
the shares being offered.
Going Concern
Our financial statements have been prepared assuming that we will continue as a
going concern and, accordingly, do not include adjustments relating to the
recoverability and realization of assets and classification of liabilities that
might be necessary should we be unable to continue in operation. Our report from
our independent registered public accounting firm for the fiscal year ended
recurring losses and limited operations which raise substantial doubt about its
ability to continue as a going concern. If the Company is unable to obtain
adequate capital, the Company may be required to reduce the scope, delay, or
eliminate some or all of its planned operations. These factors, among others,
raise substantial doubt about the Company’s ability to continue as a going
concern.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
Critical Accounting Policies and Estimates
The preparation of our financial statements requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and the disclosure of contingent assets and liabilities at the date
of the financial statements and the reported amounts of revenues and expenses
during the reporting period. On an on-going basis, management evaluates its
estimates and judgments which are based on historical experience and on various
other factors that are believed to be reasonable under the circumstances. The
results of their evaluation form the basis for making judgments about the
carrying values of assets and liabilities. Actual results may differ from these
estimates under different assumptions and circumstances. Our significant
accounting policies are more fully discussed in Note 2 to our unaudited
financial statements contained herein.
Research and Development Costs: The Company charges research and development
costs to expense when incurred in accordance with FASB ASC 730, Research and
Development. Research and development costs were
nine months ended
25
Table of Contents
Stock-Based Compensation and Other Share-Based Payments: The Company records
stock-based compensation in accordance with ASC 718, Compensation – Stock
Compensation, using the fair value method on grant date. All transactions in
which goods or services are the consideration received for the issuance of
equity instruments are accounted for based on the fair value of the equity
instruments issued. The expense attributable to the Company’s directors is
recognized over the period the amounts are earned and vested, and the expense
attributable to the Company’s non-employees is recognized when vested, as
described in Note 9, Stock Plan.
Warrants: The Company accounts for common stock warrants in accordance with
applicable accounting guidance provided in ASC 815 Derivatives and Hedging, as
either derivative liabilities or as equity instruments depending on the specific
terms of the warrant agreement. For warrants classified as equity instruments
the Company applies the Black Scholes model and expenses the fair value as
financing costs. For warrants classified as derivative financial instruments the
Company applies the
Recent Accounting Pronouncements
There were various accounting standards and interpretations issued recently,
none of which are expected to have a material effect on the Company’s
operations, financial position or cash flows.
© Edgar Online, source
[ad_2]
Source link
